Auxein Brand Vertaux 5.5 mm Pedicle Screw System— 510(k) K201457

Name: FDA 510(k) clearance K201457
Creator: U.S. Food and Drug Administration
Published: 2021-04-06

Substantially Equivalent

Auxein Medical Private Limited/71164

FDA 510(k) clearance K201457 for Auxein Brand Vertaux 5.5 mm Pedicle Screw System, Substantially Equivalent on 2021-04-06. Applicant: Auxein Medical Private Limited/71164. Device class: 2.

Clearance details

Applicant: Auxein Medical Private Limited/71164
Product code: Product code NKB
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2020-06-01
Decision date: 2021-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sonipat, IN

Download summary PDF View on FDA.gov ↗

Recent devices under product code NKB

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K261217 — AnyPlus II Spinal Fixation System2026-10-02
K263062 — NOVIX Pedicle Screw System2026-10-01
K262712 — Duet Spinal Fixation System2026-09-30
K263172 — SAS MIS Pelvic Incidence Rods2026-09-30
K252139 — Kentrospine Viktr-MIS® Pedicle screw system2026-09-27

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.